Analytical Method Validation

USP <1058> Analytical Instrument Qualification and the Laboratory Impact

April 01, 2009

Spectroscopy

In this column, Bob McDowall discusses the impact of USP general chapter 1058 on the spectroscopy laboratory.

Validation of Spectrometry Software: The Proactive Use of a Traceability Matrix in Spectrometry Software Validation, Part II: Practice

December 01, 2008

Spectroscopy

The second part of this column series on traceability matrices looks at some of the practical ways of tracing requirements from the user requirements throughout the life cycle documents.

Validation of Spectrometry Software: The Proactive Use of a Traceability Matrix in Spectrometry Software Validation, Part I: Principles

November 01, 2008

Spectroscopy

Tracing requirements from a user requirements specification throughout the life cycle is not only a very effective business tool to save time and effort in validation projects but also a regulatory expectation. This first installment of a two-part column series looks at the principles of a traceability matrix.

Validation of Spectrometry Software: Understanding the Role and Content of a Validation Master Plan

July 01, 2008

Spectroscopy

Columnist Bob McDowall discusses the role of a validation master plan (VMP) for summarizing a laboratory's approach to computer validation.

Validation of Spectrometry Software - To Patch or Not To Patch - That Is the Question

July 01, 2007

Spectroscopy

Columnist Bob McDowall discusses operating system security patches.

Mass Calibration: Special Needs for Proteomics

February 01, 2006

Spectroscopy

Part IV of this four-part series wraps up the discussion of mass calibration, covering the "new generation" attributes that have become apparent as researchers aim to meet the calibration demands of proteomics.